Medline recalls specific medical procedure kits that may allow non-sterile product use if breather pouch seals are opened. Affected kits include cone biopsy packs and biopsy trays with certain lot numbers. Consumers should check product labels for the listed references and lot numbers.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Medline is recalling medical procedure kits that could lead to using non-sterile products if the breather pouch seal is opened. This risk is serious for medical procedures requiring sterile environments, like biopsies.
The breather pouch seals on these kits may open or become unsealed, allowing non-sterile products to be used. This could lead to infections or complications during medical procedures that require sterile conditions.
Medical professionals and patients using the recalled Medline procedure kits for biopsies or similar procedures are most at risk. Those with the specific product references and lot numbers listed are affected.
Check the product label for references like DYNJ17534L (Cone Biopsy Pack) or DYNJ43076A (Biopsy Tray). Look for lot numbers such as 23KBF936, 23LBI584, or 23LBP833.
Look for the product reference codes and lot numbers listed in the recall notice to determine if your kit is affected.
If you have the affected kits, ensure the breather pouch seals are intact before use to prevent non-sterile product exposure.
The affected kits include Cone Biopsy Packs (REF DYNJ17534L), Biopsy Trays (REF DYNJ43076A), and other specific medical procedure kits with lot numbers like 23KBF936 or 23LBI584.
Check the product label for the reference codes (e.g., DYNJ17534L) and lot numbers (e.g., 23KBF936) listed in the recall notice.
Ensure the breather pouch seals are intact before use. If the seal is opened, do not use the kit and contact Medline for further instructions.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-0158-2025 — Medline Medline Hello, I own a Medline that is covered by recall Z-0158-2025 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.